Analytical Method Development and Validation for the Simultaneous Estimation of Sulfadiazine and Pyrimethamine by RP-HPLC Method

Abstract

Background Sulfadiazine and Pyrimethamine is a combination drug of choice to treat malaria and used in those living in or will be travelling to an area where there is chance of getting malaria. Objective The main objective of the study was to validate the simultaneous estimation and the method established with resisting small changes in flow rate and ratio of organic compounds and proposed method ensures its use in routine quality control analysis of pharmaceutical formulation. MethodologyA HPLC AllianceWater 2695 with UVVIS DetectorPDA detector UV lab India UV 3000 series and Zodiac C18 250 mm times 4.6 mm times 5 microm column were used. A new method was established for simultaneous estimation of Sulfadiazine and Pyrimethamine by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Sulfadiazine and Pyrimethamine by using Zodiac sil C18 column 4.6times150 mm 5micro flow rate was 1mLmin mobile phase ratio was 7030 vv methanolphosphate buffer KH2 PO4 and K2 HPO4 phosphate pH 3 pH was adjusted with orthophosphoric acid detection wavelength was 240 nm. Results The results were in good agreement with those obtained with official HPLC with maximum absorption of 240 nm by preparing mobile phase 7030 methanolphosphate buffer with flow rate 1 mLmin and was run for 10 minutes by selecting column Zodiac silica RP C18 4.5times100 mm 3.0 microm of ambient temperature. All the results were obtained with good precision accuracy and robustness as per ICH guidelines. Conclusion It can be concluded that the proposed RPHPLC method was accurate precise sensitive specific robust and reproducible for the simultaneous analysis of Sulfadiazine and Pyrimethamine with less tailing factor and also economical. Zodiac sil C18 column 4.6times150mm5micro flow rate was 1mLmin mobile phase ratio was 7030 vv methanol phosphate buffer KH2 PO4 and K2 HPO4 phosphate pH 3 pH was adjusted with orthophosphoric acid detection wavelength was 240 nm.